- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077124
Safe and Timely Antithrombotic Removal (STAR) Registry
March 6, 2024 updated by: CytoSorbents, Inc
Safe and Timely Antithrombotic Removal (STAR) Registry: International Registry on the Use of CytoSorb for Removal of Antithrombotic Agents in the Acute Hospital Setting
This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The STAR Registry will collect patient-level clinical data on antithrombotic removal with CytoSorb.
The decision to use CytoSorb in this clinical setting is based on the clinical rationale of mitigating the high risk of bleeding events that is directly linked to the presence of the antithrombotic agent.
This registry is to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb.
Data of retrospective and prospective patients will be included in the registry.
Safety will be assessed by collection of (at least possibly) device-related adverse events.
Data collection is done up to 30 days post-operation.
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cindy Rechner, PhD
- Phone Number: +49 30 654 99 145
- Email: star@cytosorbents.com
Study Contact Backup
- Name: Robert Wilke
- Phone Number: +49 30 654 99 145
- Email: star@cytosorbents.com
Study Locations
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Graz, Austria
- Recruiting
- Universitätsklinikum Graz
-
Principal Investigator:
- Heinrich Mächler, Univ.-Prof, MD
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Innsbruck, Austria
- Not yet recruiting
- Medizinische Universität Innsbruck
-
Principal Investigator:
- Judith Martini, Assoz. Prof., PD
-
Klagenfurt, Austria
- Recruiting
- Klinikum Klagenfurt am Wörthersee
-
Principal Investigator:
- Markus Köstenberger, MD
-
Vienna, Austria
- Recruiting
- Medical University of Vienna
-
Principal Investigator:
- Martin Bernardi, ap. Prof. PD Dr. Dr.
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-
-
-
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Aalst, Belgium
- Recruiting
- OLV ziekenhuis Aalst VZW
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Principal Investigator:
- Nikolaas De Neve, MD
-
Bruxelles, Belgium
- Recruiting
- Cliniques Universitaires Saint-Luc
-
Principal Investigator:
- Robert Tircoveanu, MD
-
-
-
-
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Coswig, Germany
- Recruiting
- MediClin Herzzentrum Coswig
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Principal Investigator:
- Thomas Eberle, MD
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Erlangen, Germany
- Recruiting
- Herzchirurgische Klinik Erlangen
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Principal Investigator:
- Rene Tandler, MD
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Essen, Germany
- Recruiting
- Universitätsklinikum Essen
-
Principal Investigator:
- Matthias Thielmann, Prof, MD
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Hamburg, Germany
- Recruiting
- Asklepios Kliniken Hamburg GmbH
-
Principal Investigator:
- Kambiz Hassan, MD
-
Hannover, Germany
- Recruiting
- Medizinische Hochschule Hannover
-
Principal Investigator:
- Jan Schmitto, Prof, MD
-
Heidelberg, Germany
- Recruiting
- Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
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Principal Investigator:
- Anna L. Meyer, Prof, MD
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Kiel, Germany
- Recruiting
- Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie
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Principal Investigator:
- Bernd Panholzer, MD
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Munich, Germany
- Recruiting
- LMU Klinikum Großhadern
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Principal Investigator:
- Michael Schmoeckel, Prof, MD
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Munich, Germany
- Recruiting
- Artemed Klinikum München Süd GmbH & Co. KG
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Principal Investigator:
- Helmut Mair, MD
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München, Germany
- Recruiting
- Deutsches Herzzentrum Munchen
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Principal Investigator:
- Keti Vitanova, PD, MD
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Nürnberg, Germany
- Recruiting
- Klinikum Nürnberg
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Principal Investigator:
- Jurij Kalisnik, Prof, MD, PhD
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Oldenburg, Germany
- Recruiting
- Klinikum Oldenburg AöR
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Principal Investigator:
- Ulf Günther, PD, MD
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Trier, Germany
- Recruiting
- Krankenhaus der Barmherzigen Brüder Trier
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Principal Investigator:
- Terrence John Donovan, MD
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Ulm, Germany
- Recruiting
- Universitätsklinikum Ulm
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Principal Investigator:
- Andreas Liebold, Prof, MD
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-
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Lund, Sweden
- Recruiting
- Skåne University Hospital Lund
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Principal Investigator:
- Sandra Lindstedt, MD, PhD
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London, United Kingdom
- Recruiting
- Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)
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Principal Investigator:
- Nandor Marczin, MD
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Sheffield, United Kingdom
- Recruiting
- Sheffield Teaching Hospitals NHS Foundation Trust
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Principal Investigator:
- Steven Hunter, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients undergoing invasive management, including surgery, who receive CytoSorb therapy for antithrombotic removal as part of their routine clinical care can be included in this registry
Description
Inclusion Criteria:
- CytoSorb utilization for antithrombotic removal
- Informed consent for prospective registry participation
Exclusion Criteria:
• Use of CytoSorb for purpose other than antithrombotic removal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bleeding complications including requirements for transfusions and other blood products
Time Frame: Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days
|
Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Storey, Prof, BSc, University of Sheffield
- Principal Investigator: Michael Schmoeckel, Prof, MD, LMU Klinikum Großhadern
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2021
Primary Completion (Estimated)
September 30, 2025
Study Completion (Estimated)
September 30, 2025
Study Registration Dates
First Submitted
September 9, 2021
First Submitted That Met QC Criteria
September 30, 2021
First Posted (Actual)
October 14, 2021
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- O05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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